JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

This subject is designed to provide detailed knowledge about the importance of

analysis of drugs in biological matrices.

Course Outcomes

Upon completion of the course, the student shall be able to understand

• Extraction of drugs from biological samples
• Separation of drugs from biological samples using different techniques
• Guidelines for BA/BE studies

UNIT - I

Extraction of drugs and metabolites from biological matrices: General need, principle and procedure involved in the Bioanalytical methods such as Protein precipitation, Liquid -Liquid extraction and Solid phase extraction and other novel sample preparation approach.

UNIT - II

Biopharmaceutical Consideration: Introduction, Biopharmaceutical Factors Affecting Drug Bioavailability, In Vitro: Dissolution and Drug Release Testing, Alternative Methods of Dissolution Testing Transport models, Biopharmaceutics Classification System. Solubility: Experimental methods. Permeability: In-vitro, in-situ and In-vivo methods.

UNIT - III

Bioanalysis and bioanalytical method validation:

• a. Types of body fluids, requirement of analysis, matrix effects, non-biological analytical samples.
• b. Bioanalytical method validation: USFDA and EMEA guidelines. Acceptance criteria in comparison to non-biological samples.

UNIT - IV

Pre-Formulation: A consideration of following characteristics of medicinal agents in their dosage form: Physical characteristics-Particle size, polymorphism, crystal form, solubility, Interfacial tension, Salt formation, wetting of solids, flow characteristics, compressibility and Partition coefficient. Chemical Characteristics-Degradation: Hydrolytic, oxidative, reductive and photolytic, Drug – Excipient compatibility studies.

UNIT - V

• a. Automation and computer-aided analysis, LIMS: The concept of auto samplers and high throughput analysis, computer-controlled instrumentation and networked laboratory. Peculiarities of laboratory information management systems (LIMS).
• b. Drug Product Performance, In Vivo: Purpose of Bioavailability Studies, Bioavailability and Bioequivalence Studies.

REFERENCES:

• 1. Analysis of drugs in Biological fluids - Joseph Chamberlain, 2nd Edition.CRC Press, New York. 1995.
• 2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
• 3. Pharmaceutical Analysis - Higuchi, Brochmman and Hassen, 2nd Edition, Wiley – Interscience Publications, 1961.
• 4. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume 11, Marcel Dekker Series
• 5. Practical HPLC method Development – Snyder, Kirkland, Glaich, 2nd Edition, John Wiley & Sons, New Jercy. USA.
• 6. Chromatographic Analysis of Pharmaceuticals – John A Adamovics, 2nd Edition, Marcel Dekker, New York, USA. 1997.
• 7. Chromatographic methods in clinical chemistry & Toxicology – Roger L Bertholf, Ruth E Winecker, John Wiley & Sons, New Jersey, USA. 2007.
• 8. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol.69, Marcel Dekker Series, 1995.
• 9. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel Dekker Series, 1989.
• 10. ICH, USFDA & CDSCO Guidelines
• 11. Palmer M.Pharm I Year II Sem (Pharmaceutical Analysis)